Message from the Associate Commissioner
Dear Women’s Health Colleagues,
As we step into a new year, understanding the impact of biological sex-based differences remains central to our work. These differences can influence various aspects of health, including disease presentation, treatment response, and overall health outcomes. In support of this critical work, I am pleased to share the publication of a new FDA draft guidance focused on the: Study of Sex Differences in the Clinical Evaluation of Medical Products. This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. Analyzing sex-related differences in medical product response is important for evaluating product safety and efficacy. These findings can inform product labeling and contribute to more informed decision-making in health care. We invite you to submit comments on this guidance and look forward to your feedback.
In addition, this month OWH is bringing broader awareness to cervical cancer, one of the most preventable and treatable cancers when detected early. Yet, each year in the United States, approximately 14,000 new cases of cervical cancer are diagnosed, and about 4,000 women die from the disease. Understanding what causes cervical cancer, how to prevent it, and why early detection matters, can help protect your health. To learn more, we invite you to read our latest Knowledge and News on Women’s Health (KNOWH) blog on: Cervical Cancer 101: What Every Woman Needs to Know.
Thank you for your continued support, and we look forward to working together this year.
Sincerely,
Kaveeta P. Vasisht, M.D., Pharm.D.
Associate Commissioner for Women’s Health Director, Office of Women’s Health (OWH)
  Maternal Health Awareness Day – January 23
From pregnancy to postpartum, maternal health matters every step of the way. FDA has information and resources to help you make good choices about medicines, foods, and other products for you and your baby. Are you expecting or thinking of becoming pregnant? Check out our pregnancy resources and talk with your health care provider about your plans.
  January is Cervical Cancer Awareness Month
Cervical cancer develops when cells in the cervix (the lower part of the uterus) start to grow abnormally. Cervical cancer is one of the most preventable and treatable cancers when detected early. Check out our latest Knowledge and News on Women’s Health (KNOWH) blog post: Cervical Cancer 101: What Every Woman Needs to Know to learn more about cervical cancer, recognizing the risk factors, and the importance of regular screenings.
 Women’s health news and updates
- Draft guidance: Study of sex differences in the clinical evaluation of medical products
Differences in physiology between females and males can lead to differences in disease manifestation, pharmacokinetics, pharmacodynamics, and response to treatment. Analyzing sex-related differences in medical product response is an important component of assessing product safety and effectiveness and can inform what goes into product labeling. This draft guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products.
- Draft guidance: Evaluation of sex-specific and gender-specific data in medical device clinical studies
This draft guidance encourages science-driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements.
- FDA issues final guidance for industry on action levels for lead in processed food intended for babies and young children
FDA issued guidance for industry on the action levels for lead in processed food intended for babies and young children. The action levels reflect the levels of lead at which the FDA may regard the food as adulterated under the Federal Food, Drug, and Cosmetic Act. The guidance titled “Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry” supports our Closer to Zero initiative to reduce dietary exposure to contaminants, including lead, in foods to as low as possible over time, while maintaining access to nutritious foods.
- Healthcare providers’ use of a concise summary to prescribe for lactating patients
In this Spotlight on CDER Science, CDER collaborated with the Center for Biologics Evaluation and Research (CBER) and outside researchers to conduct a study to explore if adding a concise summary of risk information would more succinctly communicate drug safety information to busy healthcare providers (HCPs), and, in combination with the Lactation subsection narrative in PI, support HCP clinical decision-making for lactating patients. Results of this study indicate the need to improve the mechanism of communication about the safety of drugs for breastfeeding individuals to meet the needs of time-constrained HCPs. This research advances CDER’s efforts to understand how HCPs interpret the Lactation subsection of the PI and how the PI can be improved to better communicate information to HCPs about the safety of prescription drugs used during lactation.
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FDA proposes rule to require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products
FDA announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed rule, if finalized, will help protect consumers who use talc-containing cosmetic products from harmful exposure to asbestos. This proposal is part of the agency’s work to fulfill the requirements of section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
- FDA announces release of long-term national strategy to increase the resiliency of the U.S. infant formula market
FDA released a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy builds on the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market External Link Disclaimer which was released in early 2023 in direct response to the February 2022 infant formula recall and the subsequent shortage of infant formula in the U.S. The long-term strategy identifies the actions we have taken since 2023 and focuses on our long-term goal of achieving a more robust and nimble U.S. infant formula supply.
More updates from around FDA
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